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Trial record 1 of 1 for:    terikids
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Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02201108
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : February 7, 2020
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:

Primary Objective:

To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.

Secondary Objective:

  • To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function.
  • To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
  • To evaluate the pharmacokinetics (PK) of teriflunomide.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Teriflunomide Drug: Placebo Phase 3

Detailed Description:

The study duration includes a screening period up to 4 weeks, a double-blind treatment period of up to 96 weeks, an open-label period including the remainder of the initial 96 weeks, where applicable, and a 96-week extension, i.e., up to a maximum of 192 weeks after randomization. There will be a follow-up period of 4 weeks for participants discontinuing treatment.

Within the 96 weeks double-blind treatment period, the first 4 weeks are pharmacokinetic (PK) run-in phase in which PK samples (blood samples) will be collected from participants and then 4 weeks of analysis (no samples drawn). The PK run-in phase (total 8 weeks) is intended to provide individual PK parameters to allow the dose adjustment to the 14 mg adult-equivalent dose for the rest of the study.

Participants experiencing a relapse after the PK run-in phase (8 weeks) and if confirmed by the Relapse Adjudication Panel (RAP) and patients fulfilling MRI criteria (high number of new lesions at week 36, 48 or 72 compared to previous images) will have the option to continue in an open label teriflunomide treatment arm up to 192 weeks from randomization.

An optional additional extension period is available for young participants with teriflunomide until the participants are 18 years old and/or able to switch to commercial product, whichever comes first.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension
Actual Study Start Date : July 16, 2014
Actual Primary Completion Date : October 25, 2019
Estimated Study Completion Date : September 29, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo tablets
Drug: Placebo
Pharmaceutical form:tablet Route of administration: oral

Experimental: Teriflunomide
Teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent
Drug: Teriflunomide
Pharmaceutical form:film-coated tablet Route of administration: oral
Other Name: AUBAGIO, HMR1726

Primary Outcome Measures :
  1. Time to first clinical relapse after randomization [ Time Frame: over 96 weeks ]

Secondary Outcome Measures :
  1. Proportion of relapse free participants [ Time Frame: at 24, 48, 72 and 96 weeks ]
  2. Number of of new/newly enlarged T2 lesions [ Time Frame: over 96 weeks ]
  3. Number of T1 Gd-enhancing T1 lesions [ Time Frame: over 96 weeks ]
  4. Change in volume of T2 lesions [ Time Frame: over 96 weeks ]
  5. Change in volume of T1 hypointense lesions [ Time Frame: over 96 weeks ]
  6. Number of new T1 hypointense lesions [ Time Frame: over 96 weeks ]
  7. Proportion of participants free of new or enlarged MRI T2-lesions [ Time Frame: at 48 weeks and 96 weeks ]
  8. Brain atrophy [ Time Frame: over 96 weeks ]
  9. Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test [ Time Frame: at randomization, then every 24 weeks (SDMT only) and at 96 weeks ]
  10. Safety, as assessed by clinical, laboratory, ECG, and vital signs events [ Time Frame: over 96 weeks ]
  11. Assessment of teriflunomide pharmacokinetics (PK) parameter: (Ctrough) lowest concentration of drug in the blood measured after dosing [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
  12. Assessment of teriflunomide PK parameter: (Cmax) maximum plasma drug concentration [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
  13. Assessment of teriflunomide PK parameter: (AUC0-24) area under the plasma concentration-time curve from time zero to 24 hours [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria :

  • Patients with relapsing multiple sclerosis are eligible. Patients should meet the criteria of multiple sclerosis (MS) based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 (5) and have:
  • at least one relapse (or attack) in the 12 months preceding screening or
  • at least two relapses (or attack) in the 24 months preceding screening.
  • <18 years of age and ≥10 years of age at randomization. Specific for the Russian Federation from 18 December 2014 to 26 July 2016, ≤17 years of age and ≥13 years of age at randomization
  • Signed informed consent/assent obtained from patient and patient's legal representative (parents or guardians) according to local regulations.

Exclusion criteria:

  • Expanded disability status scale (EDSS) score > 5.5 at screening or randomization visits.
  • Relapse within 30 days prior to randomization.
  • Treated with:

glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization fingolimod, or intravenous immunoglobulins within 3 months prior to randomization natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization, cladribine or mitoxantrone within 2 years prior to randomization

  • Treated with alemtuzumab at any time.
  • History of HIV infection.
  • Contraindication for magnetic resonance imaging (MRI).
  • Pregnant or breast-feeding females or those who plan to become pregnant during the study.
  • Female patients of child-bearing potential not using highly effective contraceptive method (contraception in both female and male is required).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02201108

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Sponsors and Collaborators
Genzyme, a Sanofi Company
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Genzyme, a Sanofi Company Identifier: NCT02201108    
Other Study ID Numbers: EFC11759
2011-005249-12 ( EudraCT Number )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases